List the qualities or attributes that must be controlled and tested or verified during tablet production to ensure product quality standards are met. (There are 6 of them.)
Question
List the qualities or attributes that must be controlled and tested or verified during tablet production to ensure product quality standards are met. (There are 6 of them.)
Solution
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Tablet Hardness: This is a measure of the tablet's mechanical integrity. A hardness tester is used to measure the force required to break the tablet. The hardness of a tablet can affect its disintegration and dissolution.
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Tablet Thickness: This is an important characteristic in reproducing appearance and also in counting by using filling equipment. Some filling equipment utilizes the uniform thickness of the tablets as a counting mechanism.
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Friability (Tablet Fracture Tendency): This is a measure of the tablet's ability to withstand the rigors of packaging and shipping. The test is carried out on a sample of tablets taken from the production batch.
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Disintegration: This is the time taken for a tablet to break up into granules of a certain size, or into a state in which the active ingredient is released. The disintegration test is used as a guide to the efficiency of the tablet dissolution.
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Weight Variation: This test checks the uniformity of the tablet’s weight. It involves weighing a certain number of tablets individually, calculating the average weight, and comparing the individual tablet weights to the average.
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Content Uniformity: This test ensures that each tablet contains the amount of drug substance intended with little variation. This is particularly important for drugs that have a narrow therapeutic range.
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